Cited by 0Artificial Intelligence in Healthcare and EducationMeta-analysis and systematic reviewsBiomedical Text Mining and Ontologies

Development and validation of a human-supervised AI-augmented living oncology evidence platform: a breast cancer pilot study

Open access
Rugo, H., Forsythe, A., Flora, D., Glück, S., Grieve, S., Campden, R., Liu, R.J., Musat, M. +6 more·2026·ESMO Real World Data and Digital Oncology

Abstract

Background: Oncologists face increasing difficulty staying current with rapidly evolving clinical data, guidelines, and regulatory updates. Building and maintaining an annotated clinical trial evidence library is time- and labor-intensive. To address this challenge, we developed and validated a living oncology evidence platform (Living-OEP) for breast cancer (BC), powered by an agentic artificial intelligence (AI) system that supports daily, human-conducted, AI-augmented systematic literature review (SLR). Materials and methods: The agentic AI system, incorporating GPT-4.1 and o3 (OpenAI) and Claude [Anthropic, PBC, San Francisco, CA] Sonnet-4 (Anthropic), was designed to emulate expert-led, Cochrane-compliant SLR workflows. Guided by a human-developed annotation manual, the system decomposes tasks, self-debugs, and validates outputs. Training data included 29 236 clinical trial abstracts across BC, lung, and prostate cancer, each annotated with four review and 32 extraction variables. Structured data were integrated with guideline-based treatment pathways, forming a real-time, evidence-linked OEP. Accuracy was benchmarked against 1997 human annotations. Living-OEP evidence quality was compared with AI chatbots (ChatGPT [OpenAI, San Francisco, CA], Perplexity [Perplexity AI, Inc., San Francisco, CA], Consensus [Consensus, Boston, MA], and OpenEvidence [OpenEvidence Inc., Miami, FL]) using six criteria across eight BC treatment scenarios. Results: The agentic AI review accuracy ranged from 95.1% to 97.2%. Extraction accuracy ranged from 51.1% to 99.4%, with three variables still undergoing iterative refinement. Compared with other AI tools, the Living-OEP provided more comprehensive and accurate evidence and linked all data to original publications and Food and Drug Administration labels. Conclusions: A human-conducted, AI-augmented living SLR integrated with guidelines and regulatory data can provide real-time evidence support. Future studies are required to evaluate its impact on physician workflows, clinical decision-making, and implementation in oncology practice.

AI snapshot

Written from the paper’s full text.

TL;DR

The authors developed and validated a human-supervised, agentic AI-augmented living oncology evidence platform (Living-OEP) for breast cancer, using daily Cochrane-compliant systematic literature review workflows. In this pilot, the agentic AI achieved high review accuracy and variable extraction accuracy, and the Living-OEP outperformed four comparator chatbots on descriptive evidence-quality criteria.

Key findings

  • Review accuracy ranged from 95.1% to 97.2% in the abstract; detailed results reported population 99.82%, intervention/comparator 98.75%, outcomes 93.73%, and study design 98.03% after iterative refinement.
  • Extraction accuracy ranged from 51.1% to 99.4%; examples included randomization 100.0%, phase 100.0%, clinical trial name 95.2%, clinical trial registration 100.0%, follow-up time 94.4%, sample size 90.4%, histology 99.4%, biomarker 87.8%, treatment path 61.8%, interventions 51.1%, and observation time 34.0%. Three variables—analysis type, subgroup names, and subgroup data—were not yet incorporated into the AI training pipeline and were annotated manually.
  • The agentic AI annotated 1,997 publications in 7.25 h in a single continuous session, versus an estimated 174.7 h for human scientists, representing a 95.9% reduction in annotation time.
  • The Living-OEP consistently demonstrated all six evaluation criteria in Table 2, whereas comparator chatbots mostly showed limited, rare, minimal, or no demonstration; 23% of evidence included in the Living-OEP derived from recently published, potentially practice-changing pivotal trials.

Methods

  • Design: developmental and descriptive validation of the REAL-SLR methodology, combining an agentic AI system (GPT-4.1, o3, and Claude Sonnet-4) emulating Cochrane-compliant SLR workflows with a human-led data management system for quality control, evidence interpretation, study grouping, treatment-path assignment, and guideline/regulatory integration.
  • Data and sample: training used 29,236 clinical trial abstracts across breast, lung, and prostate cancer (9,887 full manuscripts and 19,349 conference abstracts; 9,800 breast cancer abstracts), each annotated with four review variables and 32 extraction variables; validation benchmarked against 1,997 human-annotated breast cancer publications independent of the training dataset. All data were publicly accessible clinical trial data, with no confidential individual patient-level data.
  • Comparison: eight clinically realistic breast cancer scenarios were evaluated against ChatGPT (GPT-4o), Perplexity, Consensus, and OpenEvidence using six criteria; responses were scored by a single trained researcher with a binary rubric, not blinded, and the specific comparison was determined post hoc as a descriptive validation.

Limitations

  • Stated: the search strategy was limited to PubMed and English-language publications, potentially missing Embase, Cochrane CENTRAL, regional databases, and non-English evidence; training-data biases may be propagated or amplified; the platform primarily evaluates abstract-level evidence, including conference abstracts that may omit subgroup analyses, mature safety data, and methodological details.
  • Stated: the Living-OEP has not been evaluated or approved by any regulatory authority as a clinical decision-making device; the analysis evaluates the evidence base retrospectively, and prospective validation of its “living” capabilities is planned; the chatbot comparison was not blinded, was assessed by a single researcher, did not permit inter-rater reliability assessment, and lacked formal statistical testing with confidence intervals and prespecified sample sizes.
  • Evident from the text: comparator assessment dates differed (ChatGPT, Perplexity, and Consensus accessed 24 June 2025; OpenEvidence accessed 19 July 2025), although the authors state no substantive updates occurred in the interval; GPT-5 was available but GPT-4o was selected based on preliminary testing; several extraction variables remained below 80% accuracy and three variables were still manually annotated.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1016/j.esmorw.2026.100770

Cites

8 of 9 references verified1 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

  • Findingown data

    Current accuracy for response measured is 91.5%.

    “Current accuracy values are as follows: OS measure (93.6%), median survival (83.6%), landmark survival (91.0%), observation time (34.0%), primary progression measure (89.4%), median primary progression (65.8%), landmark primary progression (84.2%), other progression measures (60.8%), median other progression (64.4%), landmark other progression (76.6%), response measured (91.5%), response data (76.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: Human annotations used as the benchmark are accurate.
  • Findingown data

    Current accuracy for OS measure is 93.6%.

    “Current accuracy values are as follows: OS measure (93.6%), median survival (83.6%), landmark survival (91.0%), observation time (34.0%), primary progression measure (89.4%), median primary progression (65.8%), landmark primary progression (84.2%), other progression measures (60.8%), median other progression (64.4%), landmark other progression (76.6%), response measured (91.5%), response data (76.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: Human annotations used as the benchmark are accurate.
  • Findingown data

    Study design classification achieved 98.03% accuracy.

    “Study design classification achieved 98.03% accuracy after refinement of systematic review and meta-analysis identification.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: Human annotations used as the benchmark are accurate.
  • Findingown data

    Within 10 iterations, the system achieved 87.2% accuracy for clinical stage.

    “Within 10 iterations, the system achieved 87.2%, 99.4%, 87.8%, 93.6%, 80.9%, 61.8%, 51.1%, and 74.5% accuracy for clinical stage, histology, biomarker, subpopulation, risk, treatment path, interventions, and intervention category, respectively.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: Human annotations used as the benchmark are accurate.
  • Findingown data

    Within the first three iterations of training, the system achieved 90.4% accuracy for sample size.

    “Within the first three iterations of training, the system achieved 100.0%, 100.0%, 95.2%, 100.0%, 94.4%, and 90.4% accuracy for the following study characteristic variables: randomization, phase, clinical trial name, clinical trial registration, follow-up time, and sample size, respectively.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: Human annotations used as the benchmark are accurate.
  • May combine two claims. 12
  • Classified as probably not a substantial claim. 10
  • May combine two claims.

    Findingnone given

    Compared with other AI tools, the Living-OEP provided more comprehensive and accurate evidence and linked all data to original publications and FDA labels.

    “Compared with other AI tools, the Living-OEP provided more comprehensive and accurate evidence and linked all data to original publications and Food and Drug Administration labels.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    The agentic AI extraction accuracy ranged from 51.1% to 99.4%, with three variables still undergoing iterative refinement.

    “Extraction accuracy ranged from 51.1% to 99.4%, with three variables still undergoing iterative refinement.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    Human scientists review ∼80 abstracts per hour and extract data from approximately four abstracts per hour, with an inclusion rate of 30% following title/abstract screening.

    “Based on institutional benchmarks, we estimated that human scientists review ∼80 abstracts per hour and extract data from approximately four abstracts per hour, with an inclusion rate of 30% following title/abstract screening. These estimates were derived from internal time-tracking data collected during the development of the annotation manual.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    The Living-OEP consistently provided guideline-concordant, evidence-graded treatment recommendations with traceable source references, whereas all comparator chatbots failed to systematically identify guideline recommendation status and evidence levels for most scenarios tested.

    “Notably, the Living-OEP consistently provided guideline-concordant, evidence-graded treatment recommendations with traceable source references, whereas all comparator chatbots failed to systematically identify guideline recommendation status and evidence levels for most scenarios tested.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    The Living-OEP consistently included guideline-recommended treatments, pivotal new trials, and actionable clinical data, whereas other AI tools frequently omitted recent therapeutic advances or failed to specify guideline categories and evidence levels.

    “The Living-OEP consistently included guideline-recommended treatments, pivotal new trials, and actionable clinical data, whereas other AI tools frequently omitted recent therapeutic advances or failed to specify guideline categories and evidence levels.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Study design and conductnone given

    Three variables (analysis type, subgroup names, and subgroup data) have yet to be incorporated into the AI training pipeline and are currently annotated manually by trained scientists within the Living-OEP.

    “Three variables have yet to be incorporated into the AI training pipeline: analysis type, subgroup names, and subgroup data. These variables are currently annotated manually by trained scientists within the Living-OEP.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductreasoning

    Accuracy metrics are reported as point estimates; formal statistical testing with confidence intervals and prespecified sample sizes will be incorporated in future evaluations.

    “Accuracy metrics are reported as point estimates. As this study represents a descriptive benchmarking validation, formal statistical testing with confidence intervals and prespecified sample sizes will be incorporated in future evaluations.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    The comparison between the Living-OEP and AI chatbots was not blinded and was assessed by a single researcher.

    “The comparison between the Living-OEP and AI chatbots was not blinded and was assessed by a single researcher.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    Because the AI system is trained on human-generated annotations, any systematic biases present in the training data may be propagated and amplified.

    “Because the AI system is trained on human-generated annotations, any systematic biases present in the training data may be propagated and amplified.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Interpretationown data

    The agentic AI system achieved high concordance with human annotations for key trial annotation tasks and dramatically reduced the time required for evidence integration.

    “The agentic AI system achieved high concordance with human annotations for key trial annotation tasks and dramatically reduced the time required for evidence integration.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: Human annotations used as the benchmark are accurate.
  • Probably not a substantial claim: may not pass S2 (checkable).

    Interpretationreasoning

    This approach offers oncologists a scalable framework for structured oncology evidence synthesis and retrieval.

    “This approach offers oncologists a scalable framework for structured oncology evidence synthesis and retrieval.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Study design and conductnone given

    Restricting the search to English-language publications may underrepresent evidence from non-English-speaking regions.

    “Additionally, restricting the search to English-language publications may underrepresent evidence from non-English-speaking regions.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The current search strategy is limited to PubMed and may miss relevant evidence indexed in Embase, the Cochrane Central Register of Controlled Trials, or regional databases.

    “The current search strategy is limited to PubMed and may miss relevant evidence indexed in Embase, the Cochrane Central Register of Controlled Trials, or regional databases.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    Although the Living-OEP is updated daily, this analysis evaluates the evidence base retrospectively.

    “Although the Living-OEP is updated daily, this analysis evaluates the evidence base retrospectively.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The Living-OEP has not been evaluated or approved by any regulatory authority as a clinical decision-making device.

    “It has not been evaluated or approved by any regulatory authority as a clinical decision-making device and its outputs should be interpreted within the context of individual patient circumstances and physician expertise.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Interpretationreasoning

    Under these assumptions, human scientists would require an estimated 174.7 h to complete the same tasks, representing a 95.9% reduction in annotation time.

    “Under these assumptions, human scientists would require an estimated 174.7 h to complete the same tasks, representing a 95.9% reduction in annotation time.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The Living-OEP is intended as an informational tool to support, not replace, clinical judgment.

    “It is important to note that the Living-OEP is intended as an informational tool to support, not replace, clinical judgment.”
    Quote in the paperNot a substantial claim
  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductreasoning

    Although database searches included publications from 2019 onward, guidelines and regulatory approvals were cross-checked to include critical-path studies referenced in regulatory labels, guideline recommendations, and major conferences regardless of publication date.

    “Although database searches included publications from 2019 onward, guidelines and regulatory approvals were cross-checked to include critical-path studies referenced in regulatory labels, guideline recommendations, and major conferences regardless of publication date.”
    Quote in the paperSubstantial claim
18 of 18
  • The paper relies on this without support.

    Conference abstracts frequently omit subgroup analyses, mature safety data, and methodological details.

    “Because conference abstracts frequently omit subgroup analyses, mature safety data, and methodological details, certain extraction variables continue to require expert review and reconciliation across full-text publications, guidelines, regulatory documents, and trial registries.”
  • The paper relies on this without support.

    Human annotations used as the benchmark are accurate.

    “Accuracy was defined as the percentage of AI annotations exactly matching human annotations in both content and format.”
  • The paper relies on this without support.

    The agentic AI system's accuracy on the 1997-publication validation set generalizes to daily use on new publications.

    “The agentic AI system’s review and extraction accuracy was benchmarked against 1997 human-annotated BC publications independent of the training dataset.”
3 of 3

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • Abstract extraction-accuracy minimum excludes observation time

    Minor

    The abstract states that extraction accuracy starts at 51.1%, whereas the Results report 34.0% accuracy for observation time.

  • Abstract extraction-accuracy maximum excludes 100% results

    Minor

    The abstract caps extraction accuracy at 99.4%, but the Results report 100.0% accuracy for several study-characteristic variables.

  • More than three extraction variables remain under refinement

    Minor

    The abstract says three variables are still undergoing iterative refinement. The Results say all variables below 80% remain under active iterative development and list more than three, including treatment path, interventions, intervention category, and observation time.

3 of 3

Cites

Flagged first, then by citations

Research works printed but not linked: 1

  1. Guy, 2020, Economic burden of cancer survivorship among adults in the United States, Cancer Epidemiol Biomarkers Prev, 29, 1304

Authors
Rugo, H., Forsythe, A., Flora, D., Glück, S., Grieve, S., Campden, R., Liu, R. J., Musat, M., Rege, J. M., Kaufman, P. A., Coleman, R. L., Tarantino, P., O’Shaughnessy, J., & Schwartzberg, L.
Affiliations
  • City of Hope (US)
  • Zoo Miami (US)
  • St. Elizabeth Healthcare (US)
  • University of Vermont Medical Center (US)
  • Texas Oncology (US)
  • Harvard University (US)
  • Renown Health (US)
Corresponding author
Forsythe, A.
Venue
ESMO Real World Data and Digital Oncology
Publisher
Elsevier BV
Published
2026-09
Volume
13
Pages
100770
ISSN
2949-8201 (ISSN-L)
OpenAlex
W7204910734
Cited by
0
References
4
FWCI
0.00
Type
journal article
Language
en
Open access
Locations
  • ESMO Real World Data and Digital Oncology (publishedVersion, cc-by-nc-nd)
  • PubMed Central (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
Topics
  • Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Biomedical Text Mining and Ontologies
Keywords
agentic AI, breast cancer, GPT-4, Claude Sonnet 4, treatment pathways

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Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-30.

Statistics and arithmetic are recomputed, not judged.

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